[{"country_short": "USA", "city": "Plymouth", "description": "Senior Clinical Safety Specialist\nJob Requisition #: 12987\nDate Posted: 04/20/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Senior Clinical Safety Specialist will work under the direction of the Senior Director, Medical/Scientific Affairs processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects.\n\nResponsibilities:\n\u2022 Process all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting\n\u2022 Collaborate with Safety team members in preparation for DMC/DSMB/CEC meetings\n\u2022 Oversee weekly review of adverse events with applicable study teams\n\u2022 Review all adverse events in accordance with the specified Clinical Investigation Plan (CIP)\n\u2022 Code adverse events where directed by the governing processes\n\u2022 Draft AE narratives, as required, for inclusion in all FDA report submissions\n\u2022 Work with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events\n\u2022 Maintain knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products\n\u2022 Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting\n\u2022 Assist with revision or writing of SOP/Instructions/Procedures and changes to support clinical department\n\u2022 Assist in development of study specific case report forms\n\u2022 Assist in clinical study protocol development\n\u2022 Assist with BIMO audits, when directed\n\u2022 Collaborate on additional Clinical Research activities, as needed\n\u2022 Other duties as assigned\n\nRequirements:\n\u2022 Bachelor\u2019s degree in an area of science or RN\n\u2022 Strong understanding of adverse events and risk assessment\nOne of the following:\n\u2022 2-5 years experience within pharmacovigilance or medical safety\n\u2022 5+ years experience in medical device or Pharma in\nclinical research or risk assessment\n\n\u2022 Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards\n\u2022 Proficient in MS Office and database navigation skills\n\u2022 Strong interpersonal and communication skills\n\u2022 Excellent record keeping, organizational skills, and problem solving abilities\n\u2022 Highly motivated and capable of working independently and as a team member\n\u2022 Experience coordinating, prioritizing, and setting timelines for multiple tasks\n\u2022 Ability to multi-task and adapt to a rapid pace environment\n\u2022 Strong technical writing skills\n\nPreferred qualifications:\n\u2022 3-5 years of experience in a hospital or clinic setting, preferably within the cardiovascular arena\n\u2022 PharmD or PhD\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-20 18:09:08", "url": "http://jobs.sjm.com/xml/28034690/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Clinical Safety Specialist", "reqid": "12987", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28034690}]